Visualisation of the microcirculation of the nasal mucosa in vivo in different nasal disorders, using sidestream dark-field imaging
ISRCTN | ISRCTN67264420 |
---|---|
DOI | https://doi.org/10.1186/ISRCTN67264420 |
Secondary identifying numbers | NTR719 |
- Submission date
- 21/07/2006
- Registration date
- 21/07/2006
- Last edited
- 05/11/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Ear, Nose and Throat
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof W J Fokkens
Scientific
Scientific
Academic Medical Centre (AMC)
Department of Otorhinolaryngology, Room A2-234
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
Phone | +31 (0)20 566 3789 |
---|---|
W.J.Fokkens@amc.nl |
Study information
Study design | Randomised controlled trial |
---|---|
Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
Scientific title | |
Study acronym | ViMiNa |
Study objectives | Xylometazoline nasal spray relieves vasoconstriction in the nasal mucosa, which will be assessed and visualised using sidestream dark-field (SDF) imaging. |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Nasal disorder |
Intervention | The microcirculation of the nasal mucosa of healthy controls will be assessed using a non-invasive probe, diameter 0.5 cm, which will be placed in the nasal cavity, twice for a period of approximately 10 minutes. Images will be recorded to make off-line analysis possible. In between the two periods of recording or measuring, the healthy volunteers will get a provocation with xylometazoline nasal spray or placebo. After a few minutes, a second measurement will be taken to assess possible differences in the microcirculation. |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Xylometazoline |
Primary outcome measure | The following parameters will be used to assess the microcirculatory reaction after provocation: Flow in the capillary, venules and arterioles can be scored semi-quantitatively or quantitatively: 1. Semi-quantitative scoring: 0 = no flow 1 = intermittent flow 2 = sluggish flow 3 = continuous flow 2. Quantitative scoring: velocity, flow, diameter, length, density |
Secondary outcome measures | No secondary outcome measures |
Overall study start date | 01/07/2006 |
Completion date | 01/12/2006 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 20 |
Key inclusion criteria | 1. Patients with active allergic rhinitis, idiopathic rhinitis, chronic rhinosinusitis or nasal polyps 2. Males or females aged over 18 years; no maximum age 3. Approval from the patient's physician 4. Written informed consent |
Key exclusion criteria | 1. Smoker 2. Severe cardiac or pulmonary disorder 3. Peripheral vascular disease 4. Medication: systemic alpha-blockers, corticosteroids (local and systemic), any local nasal treatment, bronchodilatory inhalation medication for pulmonary diseases >1000 µg/day 5. Cystic fibrosis, immotile cilia syndrome, Rendu-Osler-Weber disease, vasculitis 6. Cocaine and/or alcohol abuse |
Date of first enrolment | 01/07/2006 |
Date of final enrolment | 01/12/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Centre (AMC)
Amsterdam
1100 DD
Netherlands
1100 DD
Netherlands
Sponsor information
Academic Medical Centre (AMC) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Otorhinolaryngology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
Website | http://www.amc.uva.nl |
---|---|
https://ror.org/03t4gr691 |
Funders
Funder type
Hospital/treatment centre
Academic Medical Centre (AMC) (The Netherlands)
No information available
Results and Publications
Intention to publish date | |
---|---|
Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |